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Social Aspects of Drug Discovery, Development and Commercialization

Social Aspects of Drug Discovery, Development and Commercialization
Social Aspects of Drug Discovery, Development and Commercialization
  • Συγγραφείς: Osakwe
  • ISBN: 9780128022207
  • Εκδότης: Elsevier
  • Σελίδες: 324
  • Διαστάσεις: 152 X 229 mm
  • Έτος Έκδοσης: 2016
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69,00€
Χωρίς ΦΠΑ: 65,09€
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Επιθυμητό Σύγκριση

  • Organized in a sequence of interrelated theories and principles that provide the foundation for increased understanding of the relevant social aspects
  • Includes analysis of important new advances, key scientific and strategic issues, and overviews of recent progress in drug development
  • Provides a global perspective with examples from developed areas, such as the US, Japan, Canada and Europe, as well as faster-growing and emerging economies including Brazil, Russia, India, and China
  • Serves as an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society
Table Of Contents:
  • Dedication
  • Preface
  • Introduction
  • Section I: Pharmaceutical Industry, Society, and Governance
    • Chapter 1: Pharmaceutical Regulation: The Role of Government in the Business of Drug Discovery
      • Abstract
      • 1.1. Introduction
      • 1.2. The legal instruments
      • 1.3. The National Regulatory Authorities and Administration
      • 1.4. Analytical framework for regulatory approval: benefit–risk assessment
      • 1.5. The pharmaceutical product life cycle
      • 1.6. The global pharmaceutical industry: harmonization and partnerships
      • 1.7. Modernization of the global pharmaceutical systems: regulatory strategies, roadmap initiatives, and partnerships
    • Chapter 2: Trends in Innovation and the Business of Drug Discovery
      • Abstract
      • 2.1. Introduction
      • 2.2. Evolutionary trends in pharmaceutical innovation
      • 2.3. Advances in pharmaceutical innovation technology
      • 2.4. Select medical milestones of 2014
      • 2.5. Factors contributing to pharmaceutical innovation setback
      • 2.6. Case: challenges in antimicrobial drug discovery
      • 2.7. Consequence of innovation setback
      • 2.8. Strategies and approaches to addressing innovation failure
      • 2.9. Concluding remarks
    • Chapter 3: Cash Flow Valley of Death: A Pitfall in Drug Discovery
      • Abstract
      • 3.1. Introduction
      • 3.2. Product valuation as an investment decision-making tool
      • 3.3. Challenges associated with the valley of death
      • 3.4. Firms involved in the pharmaceutical value chain
      • 3.5. Strategies for bridging the Valley of Death and innovation failure
      • 3.6. Funding models
      • 3.7. Nongovernmental funding models
      • 3.8. Other financial concepts
      • 3.9. Private–public sector groups
  • Section II: Drug Discovery Cycle I: Discovery and Preclinical Drug Development
    • Chapter 4: Prediscovery Research: Challenges and Opportunities
      • Abstract
      • 4.1. Introduction
      • 4.2. Models of human disease biology
      • 4.3. Diseases considered in biopharmaceutical research and development
      • 4.4. Modern trends in drug discovery
      • 4.5. Current challenges in early drug discovery
    • Chapter 5: The Significance of Discovery Screening and Structure Optimization Studies
      • Abstract
      • 5.1. Introduction
      • 5.2. Screening tools in drug discovery
      • 5.3. In silico models in drug discovery and design
      • 5.4. From hit to lead: summary of compound optimization in drug discovery
    • Chapter 6: Preclinical In Vitro Studies: Development and Applicability
      • Abstract
      • 6.1. Introduction
      • 6.2. Predictability of preclinical disease models
      • 6.3. Trends in preclinical drug development
      • 6.4. Relevance of ADME/PK studies
      • 6.5. Experimental tools used in preclinical development
      • 6.6. Drug eliminating agents and mechanisms
      • 6.7. Application of zebrafish as a model whole organism: a landmark in preclinical development
    • Chapter 7: Animal Utilization in Drug Development: Clinical, Legal, and Ethical Dimensions
      • Abstract
      • 7.1. Introduction
      • 7.2. The scientific value of animal studies: pharmacology objectives
      • 7.3. Laboratory animals model in the frontiers of drug discovery
      • 7.4. Relationships in animal taxonomy and implications in pharmaceutical research and development
      • 7.5. The effect of species differences on study results
      • 7.6. How reliable is the animal toxicity information generated across the animal species?
      • 7.7. Landmarks in preclinical development: species selection and rationale
      • 7.8. Animal models in the development of biopharmaceuticals: the exceptional use of nonhuman primates
      • 7.9. Legal accommodations on the use of animals in pharmaceutical research and development
      • 7.10. Animal alternatives in drug development: replacing, reducing, and refinement of animals
    • Chapter 8: Pharmaceutical Formulation and Manufacturing Development: Strategies and Issues
      • Abstract
      • 8.1. Introduction
      • 8.2. Regulatory aspects of pharmaceutical development
      • 8.3. Formulation and manufacturing in pharmaceutical development
      • 8.4. Clinical trials materials
      • 8.5. Concepts used in pharmaceutical development
      • 8.6. Drug shortages
      • 8.7. Manufacturing problems leading to drug shortages
      • 8.8. Addressing drug shortages: strategies
  • Section III: The Drug Discovery Cycle II: Clinical Development
    • Chapter 9: Clinical Development: Ethics and Realities
      • Abstract
      • Part I.
      • Part II. Clinical development of candidate drugs
      • Part III. Clinical trial ethics
    • Chapter 10: Pharmacogenomics in Drug Discovery, Prospects and Clinical Applicability
      • Abstract
      • 10.1. Introduction
      • 10.2. Genetic variations and implications in drug development
      • 10.3. The effectiveness of clinical implementation of pharmacogenomics
      • 10.4. Promising outcomes associated with clinical application pharmacogenomics: cases
      • 10.5. Economic and social implications of pharmacogenomics application
      • 10.6. National regulatory agencies on pharmacogenomics implementation
  • Section IV: The Drug Discovery Cycle III: Authorization and Marketing
    • Chapter 11: Patents, Exclusivities, and Evergreening Strategies
      • Abstract
      • 11.1. Introduction: patents and exclusive marketing rights
      • 11.2. US Patent Law Amendments Act of 1984
      • 11.3. The interplay of patents and exclusivities during the product lifecycle
      • 11.4. Patents in the global pharmaceutical market place
      • 11.5. Evergreening
      • 11.6. Conclusions
    • Chapter 12: Drug Pricing and Control for Pharmaceutical Drugs
      • Abstract
      • 12.1. Introduction
      • 12.2. Drug assessment and pricing in various geographical locations
      • 12.3. Pharmaceutical drug pricing and ethics
    • Chapter 13: Direct-to-Consumer Advertising
      • Abstract
      • 13.1. Introduction
      • 13.2. Ethics and relevance of pharmaceutical advertising
      • 13.3. Pharmaceutical advertising and government control
      • 13.4. Prescription medicine advertising codes
      • 13.5. Conclusions
  • Index

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